(92 days)
No
The summary describes a purely mechanical implant (a metallic cage) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is intended for the reconstruction of advanced joint destruction and failed surgeries, aiming to improve patient conditions such as degenerative, post-traumatic, or rheumatoid arthritis.
No
The device description indicates it is a surgical implant (a cage) used to bridge bone loss, not to diagnose a condition.
No
The device description clearly states it is a metallic, dome-shaped, flanged acetabular component, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states this device is a "metallic, dome-shaped, flanged acetabular component" intended to be surgically implanted to "bridge the areas of acetabular bone loss."
- Intended Use: The intended use describes surgical procedures and conditions related to the hip joint, not laboratory testing of samples.
This device is a surgical implant, not a diagnostic tool used in a laboratory setting.
N/A
Intended Use / Indications for Use
This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, or total hip replacement.
Product codes
LPH
Device Description
The Zimmer Trabecular Metal Acetabular Revision System Cage is a device intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiencies, such as pelvic defects and discontinuities. The cage is a metallic, dome-shaped, flanged acetabular component with multiple screw holes for adjunct intraoperative peripheral stabilization of revision shell constructs.
The cage is available in five sizes configured in both right and left versions along with either short or long flanges to meet various anatomical needs. It offers intraoperative flexibility of implant orientation/positioning to accommodate patient anatomies. The cage is fabricated from Commercially Pure (CP) Titanium
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions: Engineering evaluations were performed to verify that the performance of the device would be adequate for anticipated in vivo use.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Summary of Safety and Effectiveness
AUG 0 2 2006
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Jenks
Specialist, Corporate Regulatory Affairs
Telephone: (574) 371-8354
Fax: (574) 372-4605 |
| Date: | July 26, 2006 |
| Trade Name: | Zimmer Trabecular Metal™ Acetabular Revision
System Cage |
| Common Name: | Acetabular Cage |
| Classification Name
and Reference: | Prosthesis, Hip, Semi-constrained, Metal/Polymer,
Porous, Uncemented
21 CFR § 888.3358 |
| Predicate Device: | Burch/Schneider™ Reinforcement Cage, K960678,
cleared May 3, 1996, manufactured by Zimmer
GmbH (formerly Centerpulse Orthopedics Ltd.) |
| Device Description: | The Zimmer Trabecular Metal Acetabular Revision
System Cage is a device intended to bridge the
areas of acetabular bone loss in patients with
acetabular bone deficiencies, such as pelvic defects
and discontinuities. The cage is a metallic, dome-
shaped, flanged acetabular component with multiple
screw holes for adjunct intraoperative peripheral
stabilization of revision shell constructs.
The cage is available in five sizes configured in
both right and left versions along with either short
or long flanges to meet various anatomical needs. It
offers intraoperative flexibility of implant
orientation/positioning to accommodate patient
anatomies. The cage is fabricated from
Commercially Pure (CP) Titanium |
| Intended Use: | This device is intended for cemented use only as
part of a layered construct and is indicated for
patients with conditions of, but not limited to,
acetabular dysplasia, osteoporosis, protrusio
acetabuli, cystic acetabular roof, reconstruction in
cases of defects after fracture, acetabular loosening,
tumors or revision surgery, advanced joint
destruction resulting from degenerative, post-
traumatic, or rheumatoid arthritis, and failed
previous surgery, e.g., osteosynthesis, joint
reconstruction, arthrodesis, hemi-arthroplasty, or
total hip replacement. |
| Comparison to Predicate Device: | Both the predicate and proposed devices are
intended for revision hip surgeries to bridge the
areas of acetabular bone loss in patients with
acetabular bone deficiency. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Engineering evaluations were performed to verify
that the performance of the device would be
adequate for anticipated in vivo use.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for
this device. |
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 2 2006
Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K061226
Trade/Device Name: Trabecular Metal Acetabular Revision System Cage Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: LPH Dated: July 26, 2006 Received: July 27, 2006
Dear Ms. Jenks:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning vour device in the Federal Register.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Ms. Patricia Jenks
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Halut Lener Lwo
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer Trabecular Metal™ Acetabular Revision System Cage
Indications for Use:
This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli. cystic acetabular roof. reconstruction in cases of defects after fracture. acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis. hemi-arthroplasty. or total hip replacement.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line -- Continue on another page if needed)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Hubert Lemer
(Division Sig) :-Division of Georgi, Restorative, and Neurological Devices
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510(k) Number L061226